(87 days)
No
The 510(k) summary describes a biological matrix device for soft tissue reinforcement. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on biocompatibility, mechanical properties, material characteristics, and animal studies, all typical for this type of device.
No.
The device is described as an implantable surgical matrix intended to reinforce soft tissue, not to treat or alleviate a disease or condition. It acts as a scaffold for tissue repair rather than a therapeutic agent.
No
This device is intended for implantation to reinforce soft tissue, acting as a resorbable extracellular matrix scaffold, and is used in surgical procedures, not for identifying or diagnosing a condition.
No
The device description clearly states the device is composed of porcine-derived extracellular matrix scaffolds, which are physical biomaterials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for implantation to reinforce soft tissue during surgical procedures. This is a therapeutic and structural function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a surgical matrix made of porcine-derived extracellular matrix, designed to be implanted and remodel into the body. This is a physical implant, not a reagent or instrument used to analyze biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on biocompatibility, mechanical strength, material characteristics, and animal model performance related to tissue repair and integration. These are relevant to an implantable surgical device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Gentrix Surgical Matrix Thick and Gentrix Surgical Matrix Extend are intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, and esophageal repair.
Product codes
FTM, OXH, OXK
Device Description
The Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend devices are composed of porcine-derived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied in an eight-layer sheet configuration in sizes up to 30 cm x 40 cm, and packaged in double peel-open pouches. The devices are terminally sterilized using electron beam irradiation. The implantable biomaterial is a resorbable extracellular matrix scaffold that will incorporate (remodel) into the body through cellular infiltration, capillary growth, and integration by the surrounding host tissue. Animal studies have shown device resorption in approximately 240 days.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, gastroenterological, plastic & reconstructive surgery, hernia, body wall, colon, rectal, esophageal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench - Biocompatibility Testing: The subject devices were evaluated for biocompatibility per ISO-10993 including the following: cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, subacute and subchronic toxicity and implantation, genotoxicity, hemocompatibility, and LAL endotoxin.
Bench - Mechanical Testing: Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend configurations were tested for the following: tensile strength, suture retention strength, and tear strength, and tear strength.
Bench - Material Characterization: Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend configurations were tested for the following: stiffness, moisture content, hydration uptake, and hydrated onset temperature.
Animal Testing: Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend configurations were evaluated in a pre-clinical porcine model of incisional ventral hernia repair through full device degradation and remodeling.
Clinical: No Clinical data was provided in support of this clearance.
Key results:
Biocompatibility Testing: The evaluation demonstrates that the subject devices meet the biocompatibility requirements of the ISO standard.
Mechanical Testing: The results of the mechanical testing provided evidence that the subject devices are substantially equivalent to the predicate device, and provide adequate mechanical strength for its application throughout its labeled shelf life.
Material Characterization: The results of the material characterization testing provided evidence that the subject devices are substantially equivalent to the predicate device and provide adequate performance for its application throughout its labeled shelf life.
Animal Testing: These animal studies provide evidence of full host tissue integration and demonstrate substantially equivalent performance between the subject and predicate devices. In addition, these results support the biocompatibility of the subject devices.
Key Metrics
Not Found
Predicate Device(s)
ACell, Inc. Gentrix™ Surgical Matrix 8 Layer (K162554)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 25, 2017
ACell, Incorporated % John Smith, M.D., J.D. Hogan Lovells US LLP 555 Thirteenth Street. NW Washington DC, District of Columbia 20004
Re: K170763
Trade/Device Name: Gentrix™ Surgical Matrix Thick; Gentrix™ Surgical Matrix Extend Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXH, OXK Dated: March 13, 2017 Received: March 13, 2017
Dear Dr. Smith:
This letter corrects our substantially equivalent letter of June 8, 2017. We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170763
Device Name
Gentrix Surgical Matrix Thick and Gentrix Surgical Matrix Extend
Indications for Use (Describe)
Gentrix Surgical Matrix Thick and Gentrix Surgical Matrix Extend are intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, and esophageal repair.
| Type of Use (Select one or both, as applicable) |
|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY ACell, Inc.'s Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend
March 13, 2017 Date Prepared:
Manufacturer Information
| Submitted By: | ACell, Inc.
6640 Eli Whitney Drive
Columbia, MD 21046 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Salman Elmi
VP and Deputy General Counsel; Head of Regulatory Affairs
ACell, Inc.
Phone: (410) 953-8500
Facsimile: (240) 465-8187 |
Device Name and Classification
| Trade/Proprietary Name: Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend | |
|---|---|
| Common or Usual Name: Surgical Mesh, ECM, Surgical Scaffold | |
| Regulation Name: | 21 CFR 878.3300; Surgical Mesh |
| Regulatory Class: | Class II |
| Product Code: | FTM, OXH, OXK |
| Predicate Devices: | ACell, Inc. Gentrix™ Surgical Matrix 8 Layer (K162554) |
Device Description
The Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend devices are composed of porcine-derived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied in an eight-layer sheet configuration in sizes up to 30 cm x 40 cm, and packaged in double peel-open pouches. The devices are terminally sterilized using electron beam irradiation. The implantable biomaterial is a resorbable extracellular matrix scaffold that will incorporate (remodel) into the body through cellular infiltration, capillary growth, and integration by the surrounding host tissue. Animal studies have shown device resorption in approximately 240 days.
Intended Use / Indications for Use
Gentrix Surgical Matrix Thick and Gentrix Surgical Matrix Extend are intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.
4
Summary of Technological Characteristics
Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend configurations have identical indications for use, intended use, materials, manufacturing processes, packaging materials, and sterilization requirements as the predicate device, and are identical or similar in performance characteristics when compared to the predicate Gentrix™ Surgical Matrix 8-Layer (K162554) device. The Performance evaluations described below were completed to demonstrate equivalence to the predicate device.
| | ACell, Inc.
Gentrix™ Surgical Matrix Thick and
Gentrix™ Surgical Matrix Extend | ACell, Inc.
Gentrix™ Surgical Matrix 8-Layer |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | TBD | K162554 |
| Device Class | Class II | Class II |
| Product Code | FTM, OXH | FTM, OXH |
| Classification | ECM, Surgical Mesh | ECM, Surgical Mesh |
| Intended Use /
Indications for Use | The Gentrix Surgical Matrix Thick and
Gentrix Surgical Matrix Extend are
intended for implantation to reinforce soft
tissue where weakness exists in patients
requiring gastroenterological or plastic &
reconstructive surgery. Reinforcement of
soft tissue within gastroenterological and
plastic & reconstructive surgery includes,
but is not limited to, the following
procedures: hernia and body wall repair,
colon and rectal prolapse repair, tissue
repair, and esophageal repair. | Gentrix™ Surgical Matrix 6-layer and 8-
Layer are intended for implantation to
reinforce soft tissue where weakness
exists in patients requiring
gastroenterological or plastic &
reconstructive surgery. Reinforcement of
soft tissue within gastroenterological and
plastic & reconstructive surgery includes,
but is not limited to, the following
procedures: hernia and body wall repair,
colon and rectal prolapse repair, tissue
repair, and esophageal repair. |
| Material Source | Porcine Urinary Bladder | Porcine Urinary Bladder |
| Material Type | Collagen, Extracellular Matrix | Collagen, Extracellular Matrix |
| Resorbable | Yes | Yes |
| Configuration | Sheets | Sheets |
| Nominal Sizes (cm) | Up to 30 x 40 | Up to 10 x 15 |
| Reusable | Single Use Device | Single Use Device |
| Packaging | Dual Foil:PET Pouch System | Dual Foil:PET Pouch System |
| Sterilization | electron beam irradiation | electron beam irradiation |
A table comparing the key features of the subject and predicate device is provided below.
Performance Data
Bench - Biocompatibility Testing
The subject devices were evaluated for biocompatibility per ISO-10993 including the following: cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, subacute and subchronic toxicity and implantation, genotoxicity, hemocompatibility, and LAL endotoxin. The evaluation demonstrates that the subject devices meet the biocompatibility requirements of the ISO standard.
5
Bench - Mechanical Testing
Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend configurations were tested for the following: tensile strength, suture retention strength, and tear strength, and tear strength. The results of the mechanical testing provided evidence that the subject devices are substantially equivalent to the predicate device, and provide adequate mechanical strength for its application throughout its labeled shelf life.
Bench - Material Characterization
Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend configurations were tested for the following: stiffness, moisture content, hydration uptake, and hydrated onset temperature. The results of the material characterization testing provided evidence that the subject devices are substantially equivalent to the predicate device and provide adequate performance for its application throughout its labeled shelf life.
Animal Testing
Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend configurations were evaluated in a pre-clinical porcine model of incisional ventral hernia repair through full device degradation and remodeling. These animal studies provide evidence of full host tissue integration and demonstrate substantially equivalent performance between the subject and predicate devices. In addition, these results support the biocompatibility of the subject devices.
Clinical
No Clinical data was provided in support of this clearance.
Conclusions
The Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend are as safe and effective as the Gentrix™ Surgical Matrix 8-Layer. The Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend have identical intended uses, indications, and principles of operation; additionally the subject and predicate devices have identical or similar technological characteristics. The minor technological differences between the Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend and the predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend are as safe and effective as the Gentrix™ Surgical Matrix 8-Layer. Thus, the Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend are substantially equivalent to the predicate device.